Primary PCI in Patients With ST-elevation Myocardial Infarction and Multivessel Disease: Treatment of Culprit Lesion Only or Complete Revascularization (PRIMULTI)
|ST-elevation Myocardial Infarction. Multi Vessel Disease.||Procedure: Percutaneous coronary intervention Procedure: FFR|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||Primary PCI in Patients With ST-elevation Myocardial Infarction and Multivessel Disease: Treatment of Culprit Lesion Only or Complete Revascularization (DANAMI-3-PRIMULTI) A Randomised Comparison of the Clinical Outcome After Complete Revascularisation Versus Treatment of the Infarct-related Artery Only During Primary Percutaneous Coronary Intervention|
- All cause death, myocardial infarction or revascularization [ Time Frame: 1 year ]Composite of all cause mortality, myocardial infarction, or ischemia (either subjective or objective) driven revascularization of non-culprit coronary lesions eligible for and randomized to either of the two treatment arms at the time of the index procedure
- Cardiac death or myocardial infarction [ Time Frame: 1 year ]
- Hospitalization for acute coronary syndrome or acute heart failure [ Time Frame: 1 year ]
- Angina status and quality of life [ Time Frame: 1 year ]
- Infarct size in relation to area at risk as determined by MRI [ Time Frame: 3 months ]
- Cardiac death, myocardial infarction, repeat revascularisation or occurrence of definite stent thrombosis (according to ARC definition) of non culprit lesions [ Time Frame: 2 years ]
- Wall motion index (WMI) determined by echocardiography [ Time Frame: 1 year ]
|Study Start Date:||May 2011|
|Estimated Study Completion Date:||February 2019|
|Primary Completion Date:||February 2015 (Final data collection date for primary outcome measure)|
Active Comparator: Culprit lesion revascularization
Only the culprit lesion is treated whereas other study lesions are left un-treated.
|Procedure: Percutaneous coronary intervention|
Active Comparator: Full revascularization
Culprit lesion is treated initially and all other lesions with diameter stenosis angiographically >50% and FFR <0.80 are treated in a separate procedure within the index hospitalization. Stenoses > 90% are treated without prior FFR.
|Procedure: Percutaneous coronary intervention Procedure: FFR|
STEMI patients with MVD (30% of total STEMI population) are - following successful primary angioplasty - randomized to either no additional percutaneous coronary intervention (PCI) of other lesions or full revascularisation guided by fractional flow reserve (FFR).
Eligible coronary arteries must be >2.0 mm in diameter and at the discretion of the operator suitable for PCI. Only arteries with angiographically stenoses > 50% can be randomized. All randomized lesions with diameter stenosis > 50% and < 90% are evaluated by FFR and a FFR value < 0.80 is considered significant and treated. Stenoses >90% are treated without prior FFR.
Full revascularization is a priori obtained by means of PCI. If, however, PCI is considered inferior to coronary artery bypass grafting the latter option can be chosen.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01960933
|Aalborg University Hospital|
|Aalborg, Denmark, 9100|
|Rigshospitalet, University of Copenhagen|
|Copenhagen, Denmark, 2100|
|Study Chair:||Steffen Helqvist, MD, DMSci||Rigshospitalet, University of Copenhagen, Denmark|
|Principal Investigator:||Thomas Engstrøm, MD, DMSci||Rigshospitalet, University of Copenhagen, Denmark|
|Principal Investigator:||Henning Kelbæk, MD. DMSci||Rigshospitalet, University of Copenhagen, Denmark|
|Principal Investigator:||Lars Køber, MD, Prof., DMSci||Rigshospitalet, University of Copenhagen, Denmark|